What are the responsibilities and job description for the Clinical Study Manager position at roche?
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position We are seeking a Clinical Study Manager to lead the operational execution of our secondary data use Real World Evidence (RWE) activities and international clinical studies. In this role, you will coordinate end-to-end study operations across global sites, ensuring that our clinical programs deliver high-quality data safely, efficiently, and ethically. You will work within a highly collaborative, matrixed team environment where your leadership directly helps us bring medical innovations to patients faster. Your Responsibilities Lead Study Teams: Build and guide cross-functional, borderless study teams, establishing clear accountabilities, deliverables, and a psychologically safe environment where everyone can thrive. Manage End-to-End Trial Operations: Maintain comprehensive study plans, risk mitigation strategies, site selection procedures, and vendor oversight protocols from activation through to clinical closure. Oversee Financials & Agreements: Manage study budgets, track metrics, review work orders, and negotiate study agreements to ensure highly cost-effective operations with minimal variances. Drive Global Regulatory Compliance: Ensure absolute adherence to international clinical trial guidelines (such as Good Pharmacovigilance Practices and Good Pharmacoepidemiology Practices), relevant local regulations, and inspection readiness. Direct Vendor & Site Deliverables: Maintain strict oversight of external vendors, tracking performance metrics, resolving systematic operational issues, and organizing necessary training. Develop Strategic Recruitment Plans: Analyze trial feasibility data across multiple countries to make data-driven recommendations on site distribution, patient numbers, and retention strategies. Who You Are You are a proactive, strategic operational leader with a passion for clinical excellence and cross-functional collaboration. You bring a growth mindset, excel at solving complex operational problems under tight deadlines, and possess deep listening and empathy skills that inspire your teams. To be successful in this role, you bring: Proven Clinical Leadership: Demonstrated experience leading successful study teams through all operational stages of clinical studies or secondary data use projects. Regulatory Expertise: A clear understanding and practical experience applying global clinical quality requirements, regulations, and pharmacovigilance standards. Strategic Planning & Risk Management: Strong organizational awareness with a proactive planning mindset, including the ability to embed operational contingencies. Financial & Vendor Acumen: Experience successfully managing trial budgets, processing vendor agreements, and handling external system integrations. Exceptional Communication: Well-developed written and verbal communication skills, with a proven ability to present clear directions, influence cross-functionally, and resolve conflicts. Together, we’ll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases. Join us in building a healthier future! Compensation & Benefits This position also offers an attractive benefits package. Learn more about how we reward our employees at Roche. This job is posted in multiple locations. If you're applying for the role in an alternative location where pay transparency regulations apply, the Talent Acquisition Partner will share the local pay information with you ahead of any business interview. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.